French adverse events reporting expands to enriched and functional foods

The new system, called Nutrivigilence, was announced at the end of last year and has been developed in consultation with the United States and Canada, where similar systems for reporting adverse events are already in place.

Anses says that although great progress has been made in food safety in recent decades, in particular in microbiology, the rapid development of products containing new ingredients or produced using new technology means consumers could be exposed to new dangers. These dangers, it says, must be identified as quickly as possible.

Pivotal to the new system will be health professionals, who will diagnose adverse events linked to consumption of new or novel foods and ingredients, supplements, functional foods and drinks, or foods for specific dietary purposes using a form on the Anses website.

Their reports will then be analysed by a technical committee and discussed with the companies involved and the authorities, in order to identify situations where the risk calls for public advice.

The agency is claiming that the system is innovative in the way it works, and in the number of actors who are involved in it.

Guillaume de Durat, who recently became secretary general of the French dietary supplements industry association Synadiet, told NutraIngredients.com that the programme is “a good approach”.​

“It is important to ensure the quality and safety for consumers,”​ he said. “Industry has everything to gain, and is ready to work with the authorities.”​

Where he does have reservations, however, is in the administration, use of data and how findings are communicated to the general public. Sometimes messages are overly simplified, he said.

“When observations are made, this is a good thing. But we have to pay attention that the conclusions made are not too large or too rapid.”​

It is important to understand whether the observations are due to a product or an allergy or reaction in a small number of consumers, as well as doses taken and whether products have been consumed with alcohol or other contraindications.

Pilot phase​

The pilot phase of the new scheme was launched in 2009 and covered only dietary supplements. According to Anses, this showed the efficacy of the measures.

During the year of the pilot, the number of declarations rose considerably. Between 2004 and August 2010 some 170 declarations had been made, of which over 120 were in 2009 and 2010. Twenty of these, concerning two particular situations, were deemed to require some action by the agency.

The first involved consumers confusing the name of an anticoagulent pharmaceutical called Préviscan, for treating thrombosis, with a dietary supplement called Prévision. Seven cases of confusion resulting in haemorrhaging were reported since 2004; these necessitated hospitalisation or an extended stay in hospital for those already being treated as in patients.

When the eighth case occurred in July 2010, Anses and Afssaps took steps to remind health professionals of the need for vigilance when prescribing products.

The second situation involved products containing yam extracts. Two supplement products, both in the same range, were implicated in undesirable effects in 11 individuals, of whom 6 cases suffered hepatitic lesions and required hospitalisation.

The evaluation showed that there are many subspecies of yam, and it is necessary to ensure ingredients used to not contain alcohol extracts of subspecies that could be toxic.

Anses said that in the absence of data on what sub-species are used, it could not guarantee that products are safe; it urged manufacturers of products containing yam extracts to obtain these data as rapidly as possible.